Panels › Cardiovascular › Product code DYB · Class 2
Introducer, Catheter
Regulation 870.1340
19510(k)s in 12 months (707 all time)
27recalls in 12 months (389 all time)
337recalls that name a 510(k)
Top companies in DYB
| Company | 510(k)s | Recalls |
|---|---|---|
| Cook Incorporated | 20 | 67 |
| Terumo Medical Corp. | 27 | 29 |
| Merit Medical Systems | 19 | 35 |
| Oscor, Inc. | 13 | 37 |
| ARROW INTERNATIONAL, LLC | 0 | 37 |
| Abiomed, Inc. | 6 | 28 |
| Thomas Medical Products, Inc. | 17 | 15 |
| St Jude Medical | 26 | 3 |
| Cordis Corp. | 22 | 3 |
| Boston Scientific | 16 | 6 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 3, 1989 | K893658 | PERCUTANEOUS INTRODUCER Medamicus, Inc. | DYB |
| May 19, 1989 | K891022 | INTRODUCER FOR PTCA GUIDING CATHETERS Argon Medical Corp. | DYB |
| Mar 10, 1989 | K890277 | HEMOSTASIS VALVE, WITH OR WITHOUT SIDE PORT Oscor Medical Corp. | DYB |
| Feb 22, 1989 | K884494 | DAIG OBTURATOR, CATHETER INTRODUCER Daig Corp. | DYB |
| Feb 22, 1989 | K884159 | SOFTOUCH INTRODUCER W/HEMOSTASIS VALVE & SIDEPORT Mallinckroot, Inc. | DYB |
| Dec 21, 1988 | K884104 | USCI(R) HEMAQUET(TM) INTRODUCER W/OBTURATOR C.R. Bard, Inc. | DYB |
| Dec 13, 1988 | K882657 | HARBOR S.E.A.-PORT SURGICAL ACCESSORY KIT Harbor Medical Devices, Inc. | DYB |
| Dec 2, 1988 | K883933 | INTRODUCING CATHETER Devices For Vascular Intervention, Inc. | DYB |
| Sep 28, 1988 | K881825 | MODELS SP5825/SP5835/SP5845/SP5855 PERCU. SHEATH Spectramed, Inc. | DYB |
| Aug 12, 1988 | K882221 | OVER THE NEEDLE CATHETER, ARTERIAL CATHETER NEEDLE Argon Medical Corp. | DYB |
| May 31, 1988 | K875158 | ACS FUNNEL INTRODUCER Advanced Cardiovascular Systems, Inc. | DYB |
| Feb 29, 1988 | K873100 | OLYMPUS ANGIOSCOPY SHEATH Olympus Corp. | DYB |
| Dec 15, 1987 | K873195 | SCHNEIDER-SHILEY ANGIOPORT(TM) PTCA INTRO W/HEMO Angiomedics, Inc. | DYB |
| Oct 7, 1987 | K873727 | PULL-APART INTRODUCER (SHEATH) Quinton, Inc. | DYB |
| Sep 30, 1987 | K873394 | OVAL PULL-APART SHEATH/DILATOR Quinton, Inc. | DYB |
| Jun 24, 1987 | K871153 | CATHETER INTRODUCER Angeion Corp. | DYB |
| Jun 5, 1987 | K871208 | UNIPOLAR ENDOCARDIAL SCREW-IN LEAD, MODEL 1007M Pacesetter Systems | DYB |
| Apr 27, 1987 | K870542 | VASCATH VASCULAR CATHETER PLACEMENT KIT Titan Medical, Inc. | DYB |
| Apr 22, 1987 | K871140 | ARIES PEEL AWAY PERCUTANEOUS CATHETER INTRODUCER Aries Medical, Inc. | DYB |
| Apr 20, 1987 | K871132 | PHARMACIA DELTEC SUBCLAVIAN INTRODUCERS Deltec Systems, Inc. | DYB |
| Apr 9, 1987 | K870907 | INTRODUCER, PERCUTANEOUS Med Fusion Systems, Inc. | DYB |
| Mar 18, 1987 | K870374 | PERCUTANEOUS INTRODUCER W/SIDE PORT 3 WAY STOPCOCK Daig Corp. | DYB |
| Mar 16, 1987 | K870189 | ARIES TAPERED SHEATH Aries Medical, Inc. | DYB |
| Feb 13, 1987 | K864705 | MODIFICATION (MATERIAL CHANGE) OF PEEL-AWAY SHEATH Quinton, Inc. | DYB |
| Jan 6, 1987 | K864352 | MODIFIED PEEL-AWAY INTRODUCER SET LINE Quinton, Inc. | DYB |
| Jan 6, 1987 | K863917 | CVI 8.5 FRENCH PERCUTANEOUS SHEATH INTRODUCER SYS. Cardio-Vascular Innovations, Inc. | DYB |
| Oct 10, 1986 | K863139 | TERUMO RADIFOCUS INTRODUCER KIT Terumo Medical Corp. | DYB |
| Aug 5, 1986 | K861984 | UMI CATH-SEAL, 13+14F & TRANSSEPTAL CATHETER INTRO Universal Medical Instrument Corp. | DYB |
| Jul 16, 1986 | K861238 | ANGIOMEDICS CATH SHEATH INTRODUC W/HEMOSTASIS VALV Angiomedics, Inc. | DYB |
| Jun 19, 1986 | K861951 | MODIFIED TELEFLEX MEDICAL INTRODUCER CATHETER Teleflex, Inc. | DYB |
| May 20, 1986 | K860307 | PEEL AWAY & SPLIT SHEATH PERCU CATH INTRODUCER SET Teleflex, Inc. | DYB |
| May 5, 1986 | K861082 | CORDIS CATH SHEATH INTRODUC/MID-LENGTH SHEATH SYST Cordis Corp. | DYB |
| Apr 29, 1986 | K860898 | SUBCLAVIAN INTRODUCER SET Infusaid Corp. | DYB |
| Apr 23, 1986 | K860958 | CATHETER INTRODUCER Target Therapeutics | DYB |
| Apr 16, 1986 | K855061 | CURITY PERCUTANEOUS CATHETER INSERTION KIT The Kendal Co. | DYB |
| Apr 16, 1986 | K855060 | CURITY PERCUTANEOUS CATHETER INSERTION TRAY The Kendal Co. | DYB |
| Apr 16, 1986 | K854941 | PMS PERCUTANEOUS PUNCTURE NEEDLE Professional Medical Services | DYB |
| Mar 31, 1986 | K860432 | PERCUTANEOUS INTRODUCER KIT Cormed, Inc., Sub. C.R.Bard, Inc. | DYB |
| Mar 31, 1986 | K854831 | VALVOKIT Novamed Products, Inc., CA | DYB |
| Feb 26, 1986 | K855126 | CORDIS CATHETER SHEATH INTRODUCERS,STERI-SLEEVES Cordis Corp. | DYB |
| Dec 24, 1985 | K854559 | MEDTRONIC PERMANENT LEAD INTRODUCER Medtronic Vascular | DYB |
| Dec 9, 1985 | K853072 | CORON PRES MONITOR KIT MODEL 80 LEFT KIT MODEL 90 Camino Laboratories, Inc. | DYB |
| Sep 25, 1985 | K853100 | COBE CATHETER W/GUIDEWIRE ASSEMBLY KIT Cobe Laboratories, Inc. | DYB |
| Aug 29, 1985 | K852880 | PEEL-AWAY SHEATH(A COMPONENT OF ARGON INTROD SET) Argon Medical Corp. | DYB |
| Aug 16, 1985 | K851947 | PTCA GUIDING CATHETER Cordis Corp. | DYB |
| Jul 29, 1985 | K852918 | SLIM ART J. BIP PACING LEAD USING POLY #030-2821 Telectronics, Inc. | DYB |
| Jul 29, 1985 | K852917 | SLIM ART/J-SVC IND PACING LEAD USING POLY #30-283 Telectronics, Inc. | DYB |
| Jul 29, 1985 | K852916 | SLIM VENT BIPO PACING LEAD USING A90 INSUL,#30-284 Telectronics, Inc. | DYB |
| Jun 21, 1985 | K845037 | PERCUTANEOUS ANGIOGRAPHIC NEEDLES Mallinckrodt Critical Care | DYB |
| Jun 21, 1985 | K844593 | CARDIOVASCULAR CUSTOM SURGICAL KIT Xanmed Corp. | DYB |
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